ArticleEClinicalMedicine2026
Nivolumab with definitive chemoradiotherapy for oesophageal squamous cell carcinoma (NOBEL): a multicentre, single-arm, phase 2 feasibility trial.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
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15 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: This single-arm, phase 2 trial investigated the safety, efficacy, and biomarkers associated with combining nivolumab, an immune checkpoint inhibitor, with definitive chemoradiotherapy in patients with operable or inoperable oesophageal squamous cell carcinoma (OSCC) because these have not been well established. Methods: In this multicentre, single-arm, phase 2 feasibility trial, eligible patients (aged 20-75 years) with histologically confirmed OSCC, Eastern Cooperative Oncology Group performance status of 0-1, and adequate organ and bone marrow functions were enrolled from five Japanese institutions. The treatment involved concurrent chemoradiotherapy (cisplatin and 5-fluorouracil) with nivolumab, followed by maintenance nivolumab for up to 1 year. The primary endpoint was safety, defined as ≤10% incidence of grade ≥4 non-haematological toxicity and ≤15% incidence of grade ≥3 pneumonitis. Secondary endpoints included complete response, progression-free survival, and overall survival. Biomarker analyses of 51 immuno-related genes were performed on pretreatment biopsy specimens. This trial is registered in the Japan Registry of Clinical Trials, jRCT1091220408, and was terminated early due to slow patient enrolment. Findings: Between January 2019 and September 2021, 42 patients were enrolled and included in the safety analysis set, whereas 41 patients who received at least one post-baseline tumour assessment comprised the efficacy analysis set. The trial met its primary safety endpoint with only 5% of patients (2 of 41) experiencing grade 3 pneumonitis. The most common adverse events of were oesophagitis, constipation, and lymphopenia, and no treatment-related deaths occurred. 1-year overall survival was 92.7% (95% CI 79.0-97.6), and 1-year progression-free survival was 65.4% (95% CI 48.6-77.9). The overall complete response rate was 73% (30 of 41; 95% CI 58-84%). Exploratory biomarker analyses were conducted to investigate immune-related gene expression, but these findings should be regarded as hypothesis-generating. Interpretation: Nivolumab combined with definitive chemoradiotherapy is feasible and showed acceptable toxicity in patients with OSCC. Further validation of exploratory biomarker findings is warranted in larger controlled studies. Funding: Ono Pharmaceutical.
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